An uncontrolled, open-label, phase II study in subjects with metastatic adenocarcinoma of the colon or rectum who are receiving first line chemotherapy with mFOLFOX6 (oxaliplatin/ folinic acid/5-fluorouracil [5-FU]) in combination with regorafenib - ND
- Conditions
- Metastatic adenocarcinoma of the colon or rectum (metastatic CRC)MedDRA version: 9.1Level: PTClassification code 10052358
- Registration Number
- EUCTR2010-020121-41-IT
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 41
•Male or female subjects aged ? 18 years •Histological or cytological documentation of adenocarcinoma of the colon or rectum •Suitable to receive mFOLFOX6 regimen as first line metastatic treatment •At least 1 measurable lesion as per RECIST version 1.1 •Unresectable or unlikely becoming resectable metastatic disease •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 •Life expectancy of at least 3 months •Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to first dose of study treatment •Total bilirubin = 1.5 x the upper limit of normal (ULN) •Alanine transaminase (ALT) and aspartate aminotransferase (AST) = 2.5 x ULN (= 5 x ULN for subjects with liver involvement of their cancer) •Amylase and lipase = 1.5 x the ULN •Serum creatinine = 1.5 x the ULN •Glomerular filtration rate (GFR) = 60 mL/min/1.73 m2 according to the modified diet in renal disease (MDRD) abbreviated formula •International normalized ratio (INR)/partial thromboplastin time (PTT) = 1.5 x ULN. (Subjects who are being therapeutically anticoagulated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in this parameter exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is predose as defined by the local standard of care.) •Platelet count = 100000/mm3, hemoglobin (Hb) = 9 g/dl, absolute neutrophil count (ANC) = 1500/mm3 •Alkaline phosphatase limit = 2.5 x ULN (= 5 x ULN for subjects with liver involvement of their cancer) •Spot urine must not show 1+ or more protein in urine or the subject will require a repeat urinalysis. If repeat urinalysis shows 1+ protein or more, a 24 hour urine collection will be required and must show total protein excretion <1000 mg/24 hours •Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment. •Women of childbearing potential and men must agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) since signing of the informed consent form until at least 6 months after the last study treatment administration. The investigator or a designated associate is requested to advise the subject how to achieve an adequate birth control. •Signed informed consent must be obtained before any study specific procedure. Subjects must be able to understand and willing to sign the written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter the study. •Prior systemic anticancer therapy for metastatic CRC. Adjuvant chemotherapy for CRC (Stage I, II, III) is permitted, if the adjuvant therapy ended > 6 months before screening and recurrent disease was documented. •Prior treatment with anti-VEGF agents and any STIs •Previous or concurrent cancer that is distinct in primary site or histology from CRC within 5 years prior to screening, EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta , Tis and T1 ). •Pregnant or breastfeeding subjects. Women of childbearing potential not employing adequate contraception or < 2 years from last menstruation. •Congestive heart failure = NYHA class II •Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study treatment. •Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) •Uncontrolled hypertension (systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg despite optimal medical management) •Subjects with phaeochromocytoma •Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study treatment •Ongoing infection > Grade 2 NCI - CTCAE v4.0. •Known history of human immunodeficiency virus (HIV) infection •Active or chronic hepatitis B or C infection with a need for antiviral treatment •Subjects with symptoms, signs, or history of brain metastases (in the case of suspected brain metastases, a cranial CT/MRI is required to exclude brain metastases) •History of organ allograft •Subjects with evidence or history of bleeding diathesis. •Any hemorrhage or bleeding event = CTCAE Grade 3 within 4 weeks of start of study treatment •Nonhealing wound, ulcer, or bone fracture •Renal failure requiring hemo-or peritoneal dialysis •Dehydration = CTCAE Grade 1 •Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results •Known hypersensitivity to any drug of study treatment, study drug classes, or excipients in the formulation •Any illness or medical conditions that are unstable or could jeopardize the safety of the subject and his/her compliance in the study •Interstitial lung disease with ongoing signs and symptoms at the time of informed consent •Subjects unable to swallow oral medications •Any malabsorption condition •Close affiliation with the investigational site (eg, a close relative of the investigator, dependent person [eg, employee or student of the investigational site]) •Known dihydropyrimidine dehydrogenase deficiency •Sensory neuropathy (> CTCAE Grade 1), unresolved toxicity > CTCAE Grade 1 attributed to any prior therapy/procedure excluding alopecia •Use of any herbal remedy (eg, St. John`s wort [Hypericum perforatum]) •Pernicious anemia or other anemias due to vitamin B12 deficiency •Subjects with seizure disorder requiring medications •Major surgery, open biopsy, or significant traumatic injury within 4 weeks prior to first dose of study treatment. Minor surgery within 2 weeks prior to first dose of study treatment. Subjects must have recovered from all
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method